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Prospective Randomized Study of Doxorubicin-Eluting-Bead Embolization in the Treatment of Hepatocellular Carcinoma: Results of the PRECISION V Study

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      Abstract

      Transcatheter arterial chemoembolization (TACE) offers a survival benefit to patients with intermediate hepatocellular carcinoma (HCC). A widely accepted TACE regimen includes administration of doxorubicin-oil emulsion followed by gelatine sponge—conventional TACE. Recently, a drug-eluting bead (DC Bead®) has been developed to enhance tumor drug delivery and reduce systemic availability. This randomized trial compares conventional TACE (cTACE) with TACE with DC Bead for the treatment of cirrhotic patients with HCC. Two hundred twelve patients with Child-Pugh A/B cirrhosis and large and/or multinodular, unresectable, N0, M0 HCCs were randomized to receive TACE with DC Bead loaded with doxorubicin or cTACE with doxorubicin. Randomization was stratified according to Child-Pugh status (A/B), performance status (ECOG 0/1), bilobar disease (yes/no), and prior curative treatment (yes/no). The primary endpoint was tumor response (EASL) at 6 months following independent, blinded review of MRI studies. The drug-eluting bead group showed higher rates of complete response, objective response, and disease control compared with the cTACE group (27% vs. 22%, 52% vs. 44%, and 63% vs. 52%, respectively). The hypothesis of superiority was not met (one-sided P = 0.11). However, patients with Child-Pugh B, ECOG 1, bilobar disease, and recurrent disease showed a significant increase in objective response (P = 0.038) compared to cTACE. DC Bead was associated with improved tolerability, with a significant reduction in serious liver toxicity (P < 0.001) and a significantly lower rate of doxorubicin-related side effects (P = 0.0001). TACE with DC Bead and doxorubicin is safe and effective in the treatment of HCC and offers a benefit to patients with more advanced disease.

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      Most cited references 37

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      Sorafenib in advanced hepatocellular carcinoma.

      No effective systemic therapy exists for patients with advanced hepatocellular carcinoma. A preliminary study suggested that sorafenib, an oral multikinase inhibitor of the vascular endothelial growth factor receptor, the platelet-derived growth factor receptor, and Raf may be effective in hepatocellular carcinoma. In this multicenter, phase 3, double-blind, placebo-controlled trial, we randomly assigned 602 patients with advanced hepatocellular carcinoma who had not received previous systemic treatment to receive either sorafenib (at a dose of 400 mg twice daily) or placebo. Primary outcomes were overall survival and the time to symptomatic progression. Secondary outcomes included the time to radiologic progression and safety. At the second planned interim analysis, 321 deaths had occurred, and the study was stopped. Median overall survival was 10.7 months in the sorafenib group and 7.9 months in the placebo group (hazard ratio in the sorafenib group, 0.69; 95% confidence interval, 0.55 to 0.87; P<0.001). There was no significant difference between the two groups in the median time to symptomatic progression (4.1 months vs. 4.9 months, respectively, P=0.77). The median time to radiologic progression was 5.5 months in the sorafenib group and 2.8 months in the placebo group (P<0.001). Seven patients in the sorafenib group (2%) and two patients in the placebo group (1%) had a partial response; no patients had a complete response. Diarrhea, weight loss, hand-foot skin reaction, and hypophosphatemia were more frequent in the sorafenib group. In patients with advanced hepatocellular carcinoma, median survival and the time to radiologic progression were nearly 3 months longer for patients treated with sorafenib than for those given placebo. (ClinicalTrials.gov number, NCT00105443.) 2008 Massachusetts Medical Society
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        Management of hepatocellular carcinoma.

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          Prognosis of hepatocellular carcinoma: the BCLC staging classification.

           J Bruix,  C Brú,  J Llovet (1998)
          The classifications of hepatocellular carcinoma (HCC) currently used are based on prognostic factors obtained from studies performed years ago when most tumors were diagnosed at advanced stages and the survival rates were substantially poor. Recent investigations have reviewed the survival of early tumors properly selected to receive radical therapies and the natural outcome of nonsurgical HCC patients. These data enable a new staging system to be proposed, the Barcelona Clinic Liver Cancer (BCLC) staging classification, that comprises four stages that select the best candidates for the best therapies currently available. Early stage (A) includes patients with asymptomatic early tumors suitable for radical therapies--resection, transplantation or percutaneous treatments. Intermediate stage (B) comprises patients with asymptomatic multinodular HCC. Advanced stage (C) includes patients with symptomatic tumors and/or an invasive tumoral pattern (vascular invasion/extrahepatic spread). Stage B and C patients may receive palliative treatments/new agents in the setting of phase II investigations or randomized controlled trials. End-stage disease (D) contain patients with extremely grim prognosis (Okuda stage III or PST 3-4) that should merely receive symptomatic treatment.
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            Author and article information

            Affiliations
            [1 ]Cardiovascular and Interventional Radiology, Medical University Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria
            [2 ]University of Athens, Athens, Greece
            [3 ]Goethe University, Frankfurt, Germany
            [4 ]Hospices Civils de Lyon, CHU, Hopital Edouard Herriot, Lyon, France
            [5 ]CHU Vaudois, Lausanne, Switzerland
            [6 ]The Peninsula Medical School, Royal Devon and Exeter Hospital, Exeter, UK
            [7 ]Guttenberg University, Mainz, Germany
            [8 ]Hôpital Huriez, Lille, France
            [9 ]Universitätsspital Zürich, Zürich, Switzerland
            [10 ]Hopitaux Universitaires de Geneve, Geneve, Switzerland
            [11 ]Hôpital La Pitiè-Salpetrière, Paris, France
            [12 ]Hôpital Paul Brousse, Paris, France
            [13 ]Medical University Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria
            [14 ]Hôpital Archet II, Nice, France
            [15 ]Cisanello University Hospital, Pisa, Italy
            Contributors
            +43-1-404005802 , +43-1-404005830 , johannes.lammer@meduniwien.ac.at
            Journal
            Cardiovasc Intervent Radiol
            Cardiovascular and Interventional Radiology
            Springer-Verlag (New York )
            0174-1551
            1432-086X
            12 November 2009
            12 November 2009
            February 2010
            : 33
            : 1
            : 41-52
            2816794
            19908093
            9711
            10.1007/s00270-009-9711-7
            © Springer Science+Business Media, LLC and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2009
            Categories
            Clinical Investigation
            Custom metadata
            © Springer Science+Business Media, LLC and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2010

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